The top 5 medtech news stories of 2021

Wednesday, December 29, 2021

Source: Medical Design & Outsourcing

The past year saw significant changes in the medtech space. Our editorial team picked their top stories.

The lingering COVID-19 pandemic was top of mind in 2021, but there was much more going on in the medical device industry. The Life Sciences editorial team here at WTWH Media discussed their top picks during the December 17 episode of our DeviceTalks Weekly podcast.

Tom Salemi, DeviceTalks Editorial Director: Vicarious Surgical goes public

Back in 2020, Vicarious Surgical seemed like the little surgical robotics company that could — seeking to succeed in a space dominated by Intuitive, with giants including Medtronic and Johnson & Johnson seeking to enter the market. Fast forward to 2021, and Vicarious was going public through a $1.1 billion special purpose acquisition company (SPAC) deal.

“We’ve got these smaller companies carving a niche for themselves,” Tom said of the surgical robotics space. He also noted that the deal was a great sign for medtech exiting-wise.

SPACs in medtech and many other industries have become a popular tool to take young companies public. Other notable medtech-related SPAC deals announced in 2021 included prescription digital therapeutics platform company Better Therapeutics, point of care diagnostic testing company LumiraDx, robotic surgery company Memic Innovative Surgery , genomic and diagnostic testing company Prenetics, and prescription digital therapeutics pioneer Pear Therapeutics.

Chris Newmarker, Executive Editor: Supply chain problems aren’t going away

Pandemic-related supply chain problems dogged medical device companies in 2021. ResMed cited them as a reason why it wasn’t able to better take advantage of competitor Philips’ major recall in the sleep and respiratory care products space. Both Medtronic and Johnson & Johnson mentioned supply chain when announcing delays related to their efforts to take on Intuitive in the surgical robotics space. And GE Healthcare’s business “largely is a supply chain story right now,” GE Chair and CEO Larry Culp said in September.

Culp specifically cited semiconductors, resin and logistics as supply chain barriers to meeting “strong, if not robust” demand.

Don’t expect the supply chain problem to go away post-pandemic, either. As MDO managing editor Jim Hammerand detailed in a feature story in November, climate change is increasingly causing problems: “Superstorms, fires, droughts and other extreme events driven by climate change are already straining the industry’s supply chain — and it could get a lot worse.”

Pharma editor Brian Buntz thinks medical device companies and manufacturers in general may need to rethink their supply chain paradigm: “The old model of supply chain was based on lean. … You have a national disaster, you have COVID — and that takes a nosedive.”

Brian Buntz, Pharma Editor: FDA approval of the Pfizer/BioNTech vaccine

Pfizer/BionNTech, Moderna and Johnson & Johnson all have COVID-19 vaccines available in the U.S. But the shot made by Pfizer and its German partner BioNTech is the only one with official FDA approval — popular in the U.S. and around the world.

Brian thinks that the Pfizer/BionNTech COVID vaccine, along with Moderna’s vaccine, helped catalyze interest in mRNA therapeutics by years, maybe even decades. It helped change the dynamics of mRNA research. “Before the pandemic, you had mRNA-based companies, but they were mainly focused on novel indications. … COVID-19 happened, and that all changed.”

There’s now inspiration for mRNA vaccines for other viruses, cancer and potentially heart indications. “Odds are, we’ll see more than just vaccines in the future,” Brian said.

Interest in mRNA could also fuel research in related platforms, such as cell and gene therapy.

Danielle Kirsh, Senior Editor: A pediatric device renaissance

The pediatric heart device market had a handful of innovations throughout this year. One of those devices is Abbott’s Amplatzer Piccolo that the company designed to treat patent ductus arteriosus (PDA) in the hearts of premature babies.

Abbott’s Piccolo is a catheter-delivered device that was originally approved for FDA use in 2019. It is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart to treat one of the most common congenital birth defects. It’s the size of a small pea and fits into the heart of a premature baby.

Physicians and surgeons often have to use products that aren’t approved for use in children. Sometimes they use a liver stent made for adults as a heart valve in kids.

Abbott isn’t alone in building medical devices specifically for kids and pediatric diseases rather than miniaturizing an adult product for a child. The National Capital Consortium for Pediatric Device Innovation announced in early December five electrophysiology devices that could monitor and treat congenital heart disease and arrhythmia in pediatric patients. The devices include: PeriCor’s TeriTorq, Inkspace Imaging’s MRI Coils, Karios Technologies: Tissue Shield, Sibel: Anne One and the Starlight Cardiovascular Project Lifeline.

The FDA has done a lot of work to make it easier for companies with pediatric products to enter the medical device space. It has created a nationwide funding program and a consortium program that sponsors several pediatric medical device consortiums across the U.S. and funds pediatric medical device contracts. The FDA also connects industry professionals and people who know how to commercialize a device to help inventors bring their own devices to market.

“I just think we’re going to see a lot of innovation in pediatrics soon. There’s going to be a pediatric device renaissance happening. That’s what I’m going to be looking forward to over the next five to 10 years,” Danielle said.

Sean Whooley, Associate Editor: Next-gen diabetes treatment tech on the way

A number of new innovations in the diabetes management space are set to make their way to the market soon, led by Dexcom’s G7 continuous glucose monitor (CGM). Dexcom CEO Kevin Sayer told MDO that enthusiasm for the next-generation CGM — roughly 60% smaller than the previous G6 version — is “at an all-time high.”

Sean said, “It’s clear to see they’re excited, and it’s really interesting to see what everyone is looking for in diabetes management. It’s a smaller insulin sensor.”

Dexcom’s G7 isn’t the only next-generation innovation set to enter the diabetes market next year, with Insulet’s Omnipod 5 wearable insulin pump expected to launch in early 2022 once it receives FDA clearance.

Medtronic expects its MiniMed 780G insulin pump system with the Guardian 4 sensor for continuous glucose monitoring to drive growth once approved, with the company currently in talks with the FDA.

Senseonics also anticipates major regulatory steps in 2022, with hopes that the FDA will reach an approval decision in the coming months for its Eversense 180-day CGM.

With those four companies planning for a big 2022, plus plenty more innovations across the diabetes care space, there is a lot to be excited for in the coming 12 months.

Runners up: Smart knee implants and telehealth

Zimmer Biomet scored an important first in the orthopedic device space this year with the launch of its Persona IQ smart knee implant, created in partnership with the startup Canary Medical. Expect more smart implants from the two companies in the future. Meanwhile, the U.S. Department of Health and Human Services reported an astonishing statistic near the end of 2021: a 63-fold increase in Medicare telehealth use during the COVID-19 pandemic. It’s hard to think that telehealth will ever return to pre-pandemic levels.

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